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pht 100 7
chapter 3 part 3
| Question | Answer |
|---|---|
| dna carries | genetic codes |
| rna is a component of genetic codes that | change amino acids into proteins |
| genetic engineering is the process of using | dna biotechnology for creating different drugs |
| biogenetic engineering created | insulins, antibloodclotting drugs, antiinflammatories, & viral/bacterial infection drugs |
| a therapeutic agent drug | prevents, cures, diagnoses, or relieves disease symptoms |
| baby aspirin helps those who are | at heartattack risk |
| pharmacodynamic agents are drugs that | alter bodily functions in ways desired |
| diagnostic agents are chemicals containing | radioactive isotopes use to diagnose illnesses |
| radio pharmaceuticals are | diagnostic agents |
| radio active isotopes are | unstable & produced radiative energy |
| radio pharmaceutical drugs (like nuclear medicine) uses isotopes to | visually examine organ function & biochemistry |
| prophylactic agents are | materials that prevent illnesses |
| prophylactic agents are | antiseptics, vaccines, antibiotics, etc. |
| destructive agents kill things like | bacteria, fungi, viruses, cells, etc. |
| antineoplastic drugs | fight cancer |
| pharmaceutical companies start with | long preclinical animal lab research |
| human studies on preclinical research can start when | the fda & the drug company's irb approves investigation on a new drug |
| nda means | new drug application |
| drug makers can apply for | a new nda after phase 3 |
| human studies on preclinical research results are | evaluated by advisory panel |
| new drugs will be fda approved if | benifits outweigh risks |
| out of 5000-10000 compound developments, 250 will be | preclinically tested, 5 will go in human clinical trails, & will be approved |
| the fda may fast-track some | drugs for early approval |
| it takes about 10 yrs. & $1 billion to | develop a new drug |
| extended patents allow drug companies to | recoup those costs |
| a potential generic drug that is not patented goes through | a drug approval process |
| a potential generic drug that is not patented get produced when | the brand version goes off patent |
| a potential generic drug that is not patented must be proven to be | bioequivalent to the brand name drug |
| an nda is | new drug application |
| an nda is the process by which applicants must scientifically | demonstrate that the new drug is bioequivalent to the innovator drug in the presence of the fda |
| a bioequivalent drug contains | the same active ingredient & performs in the same way & timing that an innovator/brand name drug does |
| a drug with the same active ingredient & dosage meeting the same usp-nf compendial standards can be | substituted without contacting the prescriber |
| compendial standards are | strength, quality, purity, & identity |
| some pharmaceutical generic agents may have | different salts & come in different dosage forms |
| these pharmaceutical generics alternate drugs can't be | substituted without prescriber authorization |
Created by:
frescah
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